§ 522.224. Bupivacaine.

135 words·~1 min read·/us/cfr/t21/s§ 522.224

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)Specifications. Each milliliter

(mL)of liposomal suspension contains 13.3 milligrams

(mg)bupivacaine.

(b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c)Conditions of use—(1) Dogs—(i) Amount. Administer 5.3 mg/kg (0.4 mL/kg) by infiltration injection into the tissue layers at the time of incisional closure.

(ii)Indications for use. For single-dose infiltration into the surgical site to provide local postoperative analgesia for cranial cruciate ligament surgery.

(2)Cats—(i) Amount. Administer 5.3 mg/kg per forelimb (0.4 mL/kg per forelimb), for a total dose of 10.6 mg/kg/cat, as a 4-point nerve block prior to onychectomy.

(ii)Indications for use. For use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy. [81 FR 67151, Sept. 30, 2016, as amended at 84 FR 8973, Mar. 13, 2019; 85 FR 4208, Jan. 24, 2020]